Anifrolumab (Saphnelo) effectively treats individuals with systemic lupus erythematosus. It reduces the overactivity of an immune system molecule at the heart of lupus immune system dysfunction: type 1 interferon.This article discusses some aspects of Saphenlo. Also, please see my other articles on Saphnelo: lupusencyclopedia.com/saphnelo-new-fda-approved-drug-for-lupus_______________________
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Saphnelo for Lupus: It improved lupus in all domains tested.
Anifrolumab (Saphnelo) has the lupus community excited a
Pronounced saf-NEH’-low
Research results “in a nut shell” in easy-to-understand language:
The clinical trials for anifrolumab were called the TULIP trials
TULIP comes from the full research study name: Treatment of Uncontrolled Lupus via the Interferon Pathway
How does it work?
Most (70%) of systemic lupus erythematosus (SLE) patients have high levels of interferons
Interferons cause inflammation in organs, leading to permanent organ damage
Anifrolumab competes with interferon by attaching to the attachments (receptors) on immune system cells
Normally, when interferons bind to those receptors, the immune system cells become more active. Then they alert more immune system cells to become more active and attack body organs
Anifrolumab decreases this cascade of events from happening
This leads to less inflammation
It is a biologic monoclonal antibody, so it is expensive
Anifrolumab (Saphnelo) works differently than any drug used in the past to treat lupus!
1st in its class! It is the next FDA-approved drug for lupus.
Saphnelo, an FDA-approved drug to treat lupus: How is it given?
Saphnelo is given intravenously (IV), 300 mg, every 4 weeksPremeds, like Benadryl and steroids, are not required since severe infusion reactions are rareWhat were the research results?
There was a 90% reduction of interferons at 6 months in the patients who started off with high levels
Other labs measuring lupus inflammation improved (anti-dsDNA, C3, C4, CH50)
Low white blood cell counts improved and low platelet counts improved
What other good things does Saphnelo for Lupus?
They had less disease activity
Even patients who started without high interferon levels overall improved
In TULIP-2: 57% (46 placebo vs 72 anifrolumab patients) more patients who started with high interferon levels met the primary endpoint with anifrolumab
… 58% more patients! Impressive!
When looking at all patients, a 51% higher number of patients responded to anifrolumab, including those with normal interferon levels!
You do not have to have high interferon levels to respond!
Close to twice as many patients were able to decrease their steroids to goal (25 placebo vs 45 on anifrolumab)
Lower steroids is important because higher doses of steroids cause organ damage
Anifrolumab reduced lupus flares
It especially worked well for cutaneous lupus
Look at the picture above from one of the studies
This patient had an amazing improvement. Many others did just as well
They measured skin activity with a CLASI score and looked for more than a 50% improvement
CLASI stands for Cutaneous Lupus Erythematosus Disease Area and Severity Index
Twice as many anifrolumab patients responded
-The numbers were 25% of the placebo cutaneous lupus patients responded, while 49% on anifrolumab did
How fast does it work?
Reduced disease activity was seen as early as 2 months. My patient above had this dramatic response just two weeks after her infusion.
Potential side effects of anifrolumab
When comparing side effects, it is important to know that the placebo patients were not truly “placebo”
They were receiving other lupus therapies (hydroxychloroquine, steroids, and immunosuppressants)
Most were on immunosuppressants and steroids that cause side effects themselves
The patients on anifrolumab were also on immunosuppressants and steroids
Therefore sorting out what anifrolumab may do vs the other drugs is very difficult
Here are the numbers (combination of three different anifrolumab research studies):
Around 87% of anifrolumab patients and 80% of placebo patients had side effects
This include nuisance, mild side effects
The most common were viral upper respiratory tract (URI) and throat infections (cold-like infections)
Infusion reactions were the other most common (but severe reactions were rare)
For example, 10% of the placebo (standard of care) patients had URIs, 18% on anifrolumab did
This is not surprising, interferon is important for fighting viral infections
Shingles occurred in around 6% of anifrolumab patients and 1%-2% of placebo patients
Again, not surprising since shingles is due to chicken pox virus
(MAKE SURE TO GET A SHINGLES VACCINE, SUCH AS SHINGRIX, BEFORE TREATMENT!)
6% of anifrolumab patients stopped treatment due to side effects; 3% of placebo patients stopped
Get all Vaccines to Prevent the Vast Majority of Saphnelo Side Effects
This list of side effects seen in 2% or more of patients in the Saphnelo clinical trials is ridiculously few. Most of them deal with viral infections (type 1 interferon is essential for fighting off viral infections).Shingles is an excruciating rash due to the chickenpox virus. People with systemic lupus erythematosus (SLE) are already three times more likely to get shingles than older healthy people.The vast majority of those treated with Saphnelo did not get shingles. However, five times more Saphnelo patients got shingles than those treated with placebo.I recommend all my patients get a shingles vaccine (preferably Shingrix) before starting Saphnelo. The Shingrix vaccine is 95% effective at preventing shingles.Since infections are the most common side effects seen with Saphnelo, the best thing people can do to avoid Saphnelo side effects is get vaccinated against them. For example, no properly vaccinated patients got shingles or COVID in the Saphnelo clinical trials. Therefore, strongly consider getting all of the following:
Shingrix (at least one dose before starting Saphnelo)
COVID vaccine every Fall/Winter. As of 2025, the CDC recommended that immunocompromised patients (SLE and Saphnelo patients) should get a 2nd shot (a booster of that year’s COVID vaccine) 2-6 months after their 1st COVID vaccine of the season.
Influenza (flu) shot every September/October
Prevnar-21 or Prevnar-20 (to reduce the risk of invasive pneumococcal infections and pneumonia)
Gardasil series ( to reduce the risk of human papillomavirus infections and its related cancers, which occur more commonly in SLE patients)
RSV vaccine (though most insurances will not pay for it until patients are 60 and older, but hopefully this will change in the future)
Hepatitis B vaccine series
What patients were not studied?
Patients with severe kidney inflammation (lupus nephritis, LN), brain, and nerve lupus (neuropsychiatric) were not
Therefore, we do not know if it works for them
However, I will go out on a limb and predict it will help LN patients (a lupus nephritis trial is being conducted with anifrolumab)
We know that interferon plays a role in LN
Just because we do not have study results for severe LN patients, this does not mean it does not work
Brain Fog and Fatigue Improved in a Patient of Mine on Saphnelo:
Fatigue, brain fog, and memory problems are some of the most common and frustrating problems from SLE. They are very difficult to improve on most lupus treatments.A patient of mind had failed all therapies, including Benlysta, then amazed me at how well he did on Saphnelo. He had to retire as a scientist at an early age due to his severe memory and fatigue problems. He wishes that we had had Saphnelo a long time ago. He could still be working in the profession he loved so much. Below is a video where I talk about my patient. Note, I did receive reimbursement for doing this video:
Bottom lines- Saphnelo for Lupus:
– Impressive results, especially for skin lupus
– Low rate of side effects (colds, sore throats, infusion reactions, shingles are the most important)
– Get your Shingrix shot before treatmentAs of August 2, 2021, anifrolumab became the next FDA-approved drug for lupus!
For more in-depth information on Saphnelo for lupus:
Read chapter 34 of The Lupus Encyclopedia, edition 2Look up your symptoms, conditions, and medications in the Index of The Lupus EncyclopediaIf you enjoy the information from The Lupus Encyclopedia, please click the “SUPPORT” button at the top of the page to learn how you can help.
What are your comments and opinions?
If you have taken Saphnelo for lupus, what has your experience been? What do you recommend for other patients?Do you have any questions to ask Dr. Thomas?Please click on “Leave a Comment” above to comment.
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Furie R, Khamashta M, Merrill JT, et al.; for the CD1013 Study Investigators. Anifrolumab, an anti-interferon-alpha receptor monoclonal antibody,in moderate-to-severe systemic lupus erythematosus.Arthritis Rheumatol. 2017;69(2):376–86.Furie R, Morand EF, Bruce IN, Manzi S, Kalunian K, Vital EM, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208–19.Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, et al.; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3): 211–21.Tanaka Y, Takeuchi T, Okada M, Ishii T, Nakajima H, Kawai S, et al. Safety and tolerability of anifrolumab, a monoclonal antibody targeting type I interferon receptor, in Japanese patients with systemic lupus erythematosus: a multicenter, phase 2, open label study. Mod Rheumatol. 2020;30(1):101–8.Tanaka Y, Tummala R. Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials. Mod Rheumatol. 2021 Jan;31(1):1-12. doi: 10.1080/14397595.2020.1812201. Epub 2020 Sep 17. PMID: 32814461.
For more in-depth information on Saphnelo for Lupus: One of Two Approved Biologics [February 2025 Update]:
This sounds amazing! I have been waiting for a drug like anifrolumab to come along.. I suffer terrible from full body rashes with my SLE along with other symptoms.
I have tried several drugs with no luck in controlling my flares. I was hoping to start IVig but my hospital wants me to go through a protocol of 2 other meds first.
This drug looks so promising for a lupus patient like myself and others who suffer with horrendous rashes. I will be speaking to my doctors about anifrolumab.
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